Search results for "manufacturing" in Articles / App Notes
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Variability challenges
“Sterile manufacturing of live viral vectors used to be the ultimate challenge in the biopharmaceutical industry,” Heller continues. Today, however, the variable nature of vi…
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Flexible Facilities for Viral Vector Manufacturing
Yet demand is growing, and flexible and efficient facilities will be needed for multi-product clinical and commercial manufacturing.
“In the viral vector space, there is diversity around different…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Through its Operation Warp Speed program for COVID-19 vaccine manufacturing, the US government is paying manufacturers and contract service providers to scale up the manufacture of specific vaccine ca…
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Good Manufacturing Practices: Challenges with Compliance
…nd Regulatory at Lubrizol Life Science’s CDMO Division; and Dino Muzzin, senior vice-president of manufacturing operations at Emergent BioSolutions, regarding the challenges contract development and …
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…ence, at AstraZeneca Biologics to get the latest on performing risk management in biopharmaceutical manufacturing.
Risk Assessment Challenges in Biopharma
BioPharm: What top challenges do com…
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Assessing Manufacturing Process Robustness
… product lifecycle, an approach that is now being applied to cleaning validation and other areas of manufacturing, as well as to clinical trials (8).
This article proposes an independent…
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Modern Manufacturing Systems Key to FDA Quality Initiative
Agency officials have urged biopharmaceutical manufacturers for more than a decade to adopt more reliable and efficient advanced manufacturing technologies capable of ensuring consistent high-quality …
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Outsourcing Trends in Biopharmaceutical Manufacturing
According to BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1), outsourcing and off-shoring have migrated into much more high-value areas…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
These therapies are fragile and require a complex manufacturing process to produce. For the earliest biologics, patents have expired or are near expiration, opening the door for follow-on generic prod…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Buffers and salts are typically the largest constituents by volume used in the downstream processing steps for manufacturing most biopharmaceutical products. A typical monoclonal antibody (mAb) proces…